Senior Vigilance Reporting Associate - Medical Device (Hybrid) | Cebu

Start Date: ASAP

Work Arrangement: Hybrid (Onsite during probationary period) | Cebu

Type of Support: Voice

Shift: 8PM - 5AM (Weekends off)

Educational Requirement:

• Bachelor’s degree in Nursing, Biology/Microbiology, Electromedical Engineering (Biomedical Engineering), Industrial/Mechanical Engineering, or other education/science/technology related discipline desired

Qualifications:

• At least 3 years of experience in writing vigilance reports for Medical Devices
• Excellent written communication in English
• Preferably with good understanding about ISO 13485, USA Medical Device Regulation
  

Job Description: 

• Adverse Event Case Processing: Take charge of collecting, entering, and thoroughly handling safety reports to ensure accuracy and timeliness.
• Medical Coding & Narratives: Skillfully validate MedDRA coding and craft comprehensive clinical narratives that tell the full story.
• Regulatory Compliance: Ensure prompt submission of Individual Case Safety Reports (ICSRs) to health authorities, strictly adhering to legal deadlines.
• Quality Review: Perform meticulous quality checks and actively support audits to maintain top-tier compliance standards.